The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

Overview

Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2017

Interventions

  • Procedure: Sentinel lymph node mapping
    • Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix. Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.

Arms, Groups and Cohorts

  • Experimental: Sentinel lymph node mapping
    • Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of sentinel lymph node frozen section
    • Time Frame: 6 months
  • Unilateral or bilateral sentinel lymph node detection rate by indocyanine green
    • Time Frame: 6 months

Secondary Measures

  • Negative and positive predictive values for sentinel lymph node frozen section
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Pathologic diagnosis of endometrial cancer – Clinical stage I or II Exclusion Criteria:

  • Contraindications for operation (hematological or coagulation disorders) – Advanced stage – Pregnancy or puerperium – Fertility preserving surgery

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ankara University
  • Provider of Information About this Clinical Study
    • Principal Investigator: salih taskin, Assoc. Prof. – Ankara University
  • Overall Contact(s)
    • Salih Taşkın, Assoc. Prof., +903125956405, salihtaskin@yahoo.com

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